MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2, GELPORT 120MM; GCJ

Model Number	C8XX2
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic liver resection "lap hand assisted colectomy" event description: "the wound protector piece of the appliance completely came apart" additional information received via email on april 04, 2018 from applied medical account manager: "i was able to find out further information on what happened through his surgical assistant, pa.First and foremost, there was no harm to the patient and they searched through the abdomen with no findings of any sheath fragments.Approximately 30-40 minutes into the lap hand assisted colectomy, when the surgeon pulled his hand out of the gelport, the alexis portion "disintegrated" and came completely apart.I inquired about if it was a fragment tear or stretch tear and she noted it was more of a fragmentation.It tore at the top of the sheath of the currently rolled down alexis where the sheath met the top ring (about half way down the sheath if you were to unroll the alexis).This was a standard procedure where nothing out of the ordinary was being performed or attempted and both the surgeon and staff are very proficient in using the gelport and alexis.There were no instruments or trocars placed through the gel of the alexis." type of intervention: "they searched through the abdomen with no findings of any sheath fragments." patient status: no patient injury occurred associated with the complaint event."there was no harm to the patient".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear originating from a puncture in the sheath.Based on the condition of the returned unit, it is likely the reported event was caused by the instrumentation used during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.

• Brand Name: C8XX2, GELPORT 120MM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7405396
• Report Number: 2027111-2018-00142
• Device Sequence Number: 35810
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)200531(30)01(10)1314904
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2020
• Device Model Number: C8XX2
• Device Catalogue Number: 700025401
• Device Lot Number: 1314904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1